Search Results for “biosimilar ” – Page 5 – media

Sandoz taps Evotec in long-term biosimilar development and manufacturing deal

As Novartis’ Sandoz unit prepares to go it alone, the off-patent medicines specialist is buckling up for the biosimilars long haul. Sandoz on Tuesday struck an accord with Just – Evotec Biologics to develop and manufacture biosimilar candidates over a multiyear stretch. The deal, which includes an “option for expansion,” marks the latest step in Sandoz’s quest to strengthen itself as a standalone company, the generics unit said in a release. The companies did not say how much they are paying for the deal. Last summer, Novartis telegraphed plans to spin off Sandoz. The decision came as part of a wider strategic review at the company that kicked off in October 2021. As of last August, the spinoff was expected to wrap up in the second half of 2023. Under its latest pact, Sandoz will get its hands on Just – Evotec Biologics’ drug substance development platform and manufacturing technology. Sandoz will use that ...
- Source: drugdu
- 203
- May 15, 2023
AbbVie weathers first months of biosimilar challenge to top-selling Humira

Ned PagliaruloLead Editor Dive Brief: AbbVie withstood the first months of U.S. copycat competition to its lucrative arthritis drug Humira about as Wall Street had expected, conceding on price to maintain insurance coverage in response to Amgen launching the country’s first biosimilar rival in January. U.S. Humira sales totaled nearly $3 billion, a decline of 26% from the same period one year ago and just over analysts’ consensus forecasts. AbbVie executives told investors on a Thursday conference call that most of that impact was driven by price changes. Amgen, which recorded $51 million in U.S. revenue for its biosimilar Amjevita, is selling its Humira rival at two different prices: a 5% discount to Humira’s nearly $90,000 annual list price, and a 55% discount. The approach is meant to address the unique demands of the U.S. healthcare system, in which insurers rely on manufacturers providing rebates off of a drug’s sticker ...
- Source: drugdu
- 164
- April 30, 2023
FDA again knocks back Alvotech’s Humira biosimilar

The copycat version of AbbVie’s blockbuster still has court clearance to launch on July 1, but only if regulators have approved it. For a second time, the Food and Drug Administration has rejected Alvotech’s Humira biosimilar, citing deficiencies spotted during a March inspection of its manufacturing facility in Iceland, the company said Thursday. The agency’s decision comes less than three months before Alvotech is free to launch the drug in the U.S. under a settlement with AbbVie, Humira’s manufacturer. Alvotech has a second FDA application pending that, if approved by June 28, would make it one of the first “interchangeable” Humira biosimilars, meaning pharmacists could directly substitute it for the branded product. An expected launch on July 1 could be delayed if the FDA doesn’t grant the main approval, which would clear the biosimilar for sale in the U.S. In a statement Thursday evening, Alvotech said it provided ...
- Source: drugdu
- 202
- April 17, 2023
Subscribe to our FREE newsletter Subscribe New EU pharma strategy looks to future-proof healthcare sector, stimulate innovation and boost access to biosimilars and generics

The new EU Pharmaceutical Strategy, adopted today by the European Commission, is designed to improve and accelerate patients’ access to safe and affordable medicines and address unmet medical needs in the areas of antimicrobial resistance, cancer, and rare diseases. It is also aiming to bolster the competitiveness and the innovative capacity of the EU’s pharma industry. Enhancing crisis preparedness and response mechanisms, and addressing security of supply, drawing lessons from the COVID-19 crisis, are also namechecked as top policy priorities in the strategy, as well as a need to guarantee a strong EU voice on the global stage by promoting a high level of quality, efficacy and safety standards. “The COVID-19 pandemic has, and continues to have, a very serious impact on Europe. Though Europe’s response has demonstrated strengths, existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines or the availability ...
- Source: drugdu
- 201
- November 29, 2020
pharma
FDA approved Pfizer biosimilar Epogen/Procrits

The FDA granted approval to Pfizer for Retacrit (epoetin alfa-epbx), which is used for the treatment of anemia, biosimilar of Amgen, a drug which generated sales closely $ 1.8 billion in the U.S market last year for Amgen and Johnson & Johnson partners. Retacrit also received the go-ahead to be used in RBC transfusions by U.S health regulators.
- Source: Ddu
- 684
- May 16, 2018
anemia New Approvals Pfizer pharma
Biogen and Samsung Bioepis Agree to Settlement with AbbVie Allowing Commercialization of IMRALDI™ (Adalimumab Biosimilar) in Europe

Biogen expects to launch IMRALDI in Europe on October 16, 2018 Biogen will be the first company to offer biosimilars of all three major anti-TNF therapies in Europe
- Source: businesswire
- 627
- April 9, 2018
AbbVie Biogen biosimilar Samsung Bioepis
Rejection–FDA Issues CLRs for Two Celltrion and Teva Biosimilars

The U.S. Food and Drug Administration (FDA) issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion. One was for a proposed biosimilar for Genentech and Biogen’s Rituxan for lymphomas and leukemias, and a proposed biosimilar to AbbVie’s Humira for rheumatoid arthritis, plaque psoriasis, Crohn’s disease and other autoimmune disorders.
- Source: biospace
- 642
- April 9, 2018
AbbVie biosimilar FDA Genentech
Amgen And Allergan Receive Positive CHMP Opinion For ABP 980 (Biosimilar Herceptin®) For The Treatment Of Three Types Of Cancer

Recommended for Approval for the Same Indications as Herceptin® (Trastuzumab) Positive Opinion for ABP 980 is Supported by Phase 3 Data in Patients With HER2-Postive Early Breast Cancer
- Source: finance.yahoo
- 608
- March 28, 2018
Allergan Amgen biosimilar herceptin New Approvals
Sandoz announces exclusive global collaboration with Biocon on next-generation biosimilars

Sandoz, a Novartis division and the global leader in biosimilars, announced a global partnership with Asia’s premier biopharmaceuticals company, Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide.
- Source: Sandoz
- 595
- January 23, 2018
biosimilars immunology Market Views oncology
Biosimilar Avastin wins EU approval

European regulators have issued a green light for Amgen and Allergan’s Mvasi, marking the first biosimilar of Roche’s Avastin to be approved in the region. The drug has been cleared to treat a range of indications spanning carcinoma of the colon or rectum, breast cancer; nonsquamous non-small cell lung cancer, renal cell cancer; platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer and cervical cancer. The companies noted that the approval came after trial data showed a high degree of similarity between Mvasi (biosimilar bevacizumab) and its reference drug, “with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products”. Mvasi is the first product borne out of an alliance between Amgen and Allergan to bag marketing authorisation from the European Commission, “highlighting the success of our joint commitment to developing cancer biosimilars,” noted David Nicholson, chief research and development officer at ...
- Source: Pharmatimes
- 567
- January 23, 2018
Avastin Mvasi New Approvals Roche

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